Apparatus and methods for treatment of obstructive sleep apnea utilizing cryolysis of adipose tissues

ABSTRACT

Methods, devices, and systems employ cryolysis of oropharyngeal adipose tissues to selectively remove fat cells from the tissues causing obstructive sleep apnea. In various embodiments, a chilled liquid—e.g., a liquid or air—is applied to the target tissue at a temperature and for a duration sufficient to cause cryolysis.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application claims priority as a continuation to U.S. Ser.No. 14/736,447, filed Jun. 11, 2015, which is a continuation of U.S.Ser. No. 13/359,000, filed Jan. 26, 2012, now U.S. Pat. No. 9,078,634the entire contents of which are hereby incorporated by referenceherein, which claims priority to and the benefits of, and incorporatesby reference herein, U.S. Ser. Nos. 61/436,712 (filed Jan. 27, 2011) and61/441,207 (filed Feb. 9, 2011).

BACKGROUND

1. Field of the Invention

The present invention relates generally to cryolytic treatment ofobstructive sleep apnea.

2. Description of Related Art

Obstructive sleep apnea (OSA) is disease that affects up to 20% of theadult population. OSA generally occurs during sleep when soft tissueObstructs the airway and creates cessation of, or impedes, breathing.Obstruction can occur at one or more levels including the retropalataland retrolingual areas. Surgical correction of such obstructions remainsa challenge, specifically for the retrolingual area. Removal or ablationof tongue tissue has been utilized with poor results due tocomplications, such as severe bleeding, abscess formation, and/or theinability to move the tongue anterior enough to relieve the obstruction.

It is known that patients with OSA have a higher percentage of adiposedeposits in the areas of obstruction, specifically, the soft palate anduvula, base of tongue and lateral pharyngeal walls. The adipose tissuemay be up to or greater than 40% of the total volume of tissues in theseareas. Removal of the fat deposits in these areas would permit relieffrom OSA symptoms while preserving surrounding tissue. To date, however,cryolytic treatment of OSA has involved procedures analogous toablation, merely substituting cryolytic cold for electrolytic heat andnonselectively destroying tissue in a similar manner—and with the samecomplications.

SUMMARY OF THE DISCLOSURE

The present invention employs cryolysis in a tissue-selective manner,selectively removing fat cells from the tissues causing OSA (e.g.,oropharyngeal tissues), and exploits the fact that fat cells are moreeasily damaged by cooling than skin cells.

Lipolysis is presently used to “dissolve” fat cells by nonsurgicalmeans. A number of methods have been attempted for lipolysis includingthe application of laser radiation, ultrasound, and radiofrequencyelectric current. Because fat cells are more easily damaged by coolingthan the tough outer skin surface, cryolysis of adipose tissues(sometimes referred to as “cryolipolysis”) has been employed by coolingtissue via thermal conduction in a controlled fashion i.e., selectingthe temperature level and exposure to avoid skin damage or frostbite andselectively damaging only the underlying fat cells. While the process isnot fully understood, it appears that fatty or adipose tissue that iscooled below body temperature but above freezing undergoes localizedcell death followed by a local inflammatory response (a localpanniculitis) that gradually, over the course of several months, reducesthe volume of the fatty tissue layer.

In various embodiments, the present invention exploits the particularcryolytic vulnerability of adipose tissue to treat OSA without damagingand/or reducing the function of oropharyngeal tissue. Certainembodiments may comprise engagement members that are formed in the shapeof each specific area to be cooled. Some embodiments may utilizegraspers capable of grasping or pinching anatomical structures (softpalate, base of tongue, soft tissue of the pharynx) associated with OSA,thereby cooling the tissue between the gripping portions and ensuringgood mechanical contact during cooling. In some embodiments, the coolingdevice may pierce the mucosa to cool the underlying tissues. The coolingdevice may also inject a cooling agent into the underlying tissue.

Accordingly, in a first aspect, the invention pertains to a device fortreatment of obstructive sleep apnea. In various embodiments, the devicecomprises a cooling unit for chilling a cooling fluid and an applicatorfor receiving the cooling fluid; the applicator is configured forcontact with oropharyngeal tissue, and the applicator and cooling unitcooperatively cause cooling of the oropharyngeal tissue to a temperaturebetween approximately 5° C. and approximately −25° C. for approximatelyone to approximately thirty minutes, whereby a volume of adipose tissuein the contacted oropharyngeal tissue is subsequently reduced. Invarious embodiments, the applicator comprises an engagement membercomplementary to a target portion of the oropharyngeal tissue, and theapplicator further includes a recirculation conduit for facilitatingheat transfer between the engagement member and the cooling fluid. Insome implementations the engagement member is flexible and conformal,while in other implementations is rigid—e.g., a substantially flatplate; “C”-shaped and complementary to a base of a tongue; or “V”-shapedand configured to engage a soft palate or a uvula. A rigid engagementmember may be hinged, and the applicator may further include a controlmember (such as a wire) facilitating closure of the engagement member tograsp tissue. If desired, the cooling unit may be configured to providesuction to the engagement member to enhance mechanical contact thereofwith the oropharyngeal tissue. In other embodiments, the applicatorcomprises a needle configured for injection of the cooling fluid intothe the target portion of the oropharyngeal tissue.

In various embodiments, the cooling fluid is a liquid, e.g., arefrigerant or a water and glycerine solution. The cooling unit may beconfigured for feedback operation to maintain a substantially constanttemperature at the target portion of the oropharyngeal tissue. Tofacilitate this, the applicator may be associated with a temperaturesensor to which the cooling unit is responsive.

In other embodiments, the cooling fluid is chilled air. For example, theapplicator may comprise a tube for introducing the chilled air into theoropharynx and an inflatable member for sealing the esophagus andpreventing the chilled air from entering the lower respiratory tract. Invarious implementations, the tube comprises inner and outer coaxiallumens, where the inner lumen has a portion extending past an end of theouter lumen and an inflatable member thereon; the cooling unit sendschilled air through the outer lumen and breathable air through the innerlumen. In other embodiments the cooling fluid is a chilled biocompatibleliquid, and the applicator comprises a tube for introducing the liquidinto the oropharynx and an inflatable member for sealing the esophagusand preventing aspiration.

In the ensuing discussion, any embodiment of any of the present devicesmethods can consist of or consist essentially of—rather thancomprise/include/contain/have—any of the described steps, elements,and/or features. Thus, in any of the claims, the term “consisting of” or“consisting essentially of” can be substituted for any of the open-endedlinking verbs recited above, in order to change the scope of a givenclaim from what it would otherwise be using the open-ended linking verb.The term “consists essentially of” means excluding other materials thatcontribute to function, unless otherwise defined herein. Nonetheless,such other materials may be present, collectively or individually, intrace amounts.

The term “coupled” is defined as connected, although not necessarilydirectly, and not necessarily mechanically; two items that are “coupled”may be integral with each other. The terms “a” and “an” are defined asone or more unless this disclosure explicitly requires otherwise. Theterms “substantially,” “approximately,” and “about” are defined aslargely but not necessarily wholly what is specified, as understood by aperson of ordinary skill in the art. In various embodiments, these termsconnote ±10% and in some embodiments ±5%.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a systemthat “comprises,” “has,” “includes” or “contains” one or more elementspossesses those one or more elements, but is not limited to possessingonly those elements. Likewise, a method that “comprises,” “has,”“includes” or “contains” one or more steps possesses those one or moresteps, but is not limited to possessing only those one or more steps.For example, in a method that comprises providing a tongue-stabilizationdevice, the method includes the specified steps but is not limited tohaving only those steps. For example, such a method could also includeinserting the device through an incision into the tongue of a patient.

Further, a device or structure that is configured in a certain way isconfigured in at least that way, but it can also be configured in otherways than those specifically described.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings illustrate by way of example and not limitation.For the sake of brevity and clarity, every feature of a given structureis not always labeled in every figure in which that structure appears.Identical reference numbers do not necessarily indicate an identicalstructure. Rather, the same reference number may be used to indicate asimilar feature or a feature with similar functionality, as maynon-identical reference numbers.

FIG. 1 depicts a side cross-sectional view of a human patient and afirst exemplary embodiment of a cooling system.

FIG. 2 depicts a side cross-sectional view of a human patient and asecond exemplary embodiment of a cooling device.

FIG. 3 depicts a side cross-sectional view of a human patient and athird exemplary embodiment of a cooling device.

FIG. 4 depicts a side cross-sectional view of a human patient and afourth exemplary embodiment of a cooling device.

FIG. 5 depicts a side cross-sectional view of a human patient and afifth exemplary embodiment of a cooling device.

FIG. 6 depicts a side cross-sectional view of a human patient and asixth exemplary embodiment of a cooling device.

FIG. 7 depicts a side cross-sectional view of a human patient and aseventh exemplary embodiment of a cooling device.

FIG. 8A depicts a side cross-sectional view of a human patient and aeighth exemplary embodiment of a cooling device.

FIG. 8B schematically depicts the tubing arrangement of the eighthexemplary embodiment shown in FIG. 8A.

FIG. 8C depicts an end view of the truing arrangement of the eighthexemplary embodiment shown in FIG. 8A.

FIG. 9 depicts a side cross-sectional view of a human patient and aninth exemplary embodiment of a cooling device.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring now to the drawings, and more particularly to FIG. 1 a coolingsystem 10 comprises a cooling device 15 including an engagement member20 configured with a substantially flat plate to engage (i.e., restagainst) the smooth surface of a patient's pharyngeal wall. In thisembodiment cooling device 15 further comprises a shaft portion 30 and acoupling member 35 distal from engagement member 20. The shaft portion30 is shown, for illustrative convenience, as extending directly fromcoupling member 35 to engagement member 20. If a straight, rigid shaftportion 30 is in fact employed, in use it would depress the tongue inorder to allow engagement member 20 to access the oropharyngeal tissuetarget. Alternatively, shaft member 35 may be curved to extend over andaround the tongue without depression thereof.

Coupling member 35 can be coupled to a cooling unit 40 via a conduit 50.It is understood that in certain exemplary embodiments, cooling device15 may be used without cooling unit 40 as explained below. In thisembodiment, cooling unit 40 can circulate a cooling agent (not visiblein the pictures) through conduit 50 and cooling device 15 to maintain adesired temperature at the target tissue. In certain embodiments,cooling device 15 can be cooled to a temperature between approximately0° C. and −20° C.

More particularly, in one embodiment, shaft portion 30 is a rigidstructure having adjacent lumens through which a chilled cooling fluidis continually circulated past engagement member 20, thereby cooling thetissue with which engagement member 20 is in contact (or moreaccurately, withdrawing heat from the tissue). The lumens terminate in apair of releasably engageable ports at the proximal end of shaft portion30. Conduit 50, in this embodiment, comprises a pair of flexible fluidlines each having a separate coupling structure for engaging one of theports, although the coupling structures are desirably integrated into asingle engagement member member 35. For example, the coupling structuresmay be snap-on sockets that receive and releasably engage flanged endsof the shaft ports in a fluid-tight manner; release of conduit 50 fromshaft portion 30 may be effected, for example, using a thumb-operatedtab on the coupling member 35. Alternatively, each conduit may have itsown coupling member (e.g., a threaded cap or other conventionalfluid-tight coupling) that individually and releasably engages one ofthe ports of shaft portion 20. The releasable coupling allows shaftportion 30 and engagement member 20 to be disposable or sterilizable,while conduits 50 are permanent.

Cooling unit 40 continually removes heat from the circulating coolantfluid to a heat sink and continuously provides the chilled coolant toshaft portion 30 and engagement member 20 via one fluid line whilewithdrawing coolant through the other fluid line. Examples of suitablecirculating coolants include water, glycol, synthetic heat transferfluid, oil, or a refrigerant. In specific embodiments, the coolantcomprises or consists essentially of a water and solute solution. In oneimplementation, the coolant comprises or consists essentially of a waterand glycerine solution comprising less than 45% glycerine by weight. Thefluid lines of conduit 50 can be hoses made of polyethylene, polyvinylchloride, polyurethane, or other flexible or rigid material that canaccommodate the particular circulating coolant. Cooling unit 40 can be arefrigeration unit, a cooling tower, a thermoelectric chiller, or anyother device capable of removing heat from a coolant. For example,cooling unit 40 can include one or more thermoelectric cooling elements,such as Peltier-type thermoelectric elements.

Cooling unit 40 may also include a processor for monitoring processparameters via one or more sensors. For example, a sensor 55 disposedwithin or against engagement member 20 can report the temperature of theengagement member 20, and the processor of cooling unit 20 mayresponsively adjust the degree of cooling of the circulating coolant; inthis way, a desired temperature (or temperature range) is achieved andmaintained in a closed-loop fashion via continuous feedback. Thetemperature sensor 55 may be connected to cooling unit via a wire alongshaft portion 30; the wire terminates in an electrical coupling at theproximal end of shaft portion 30, and this coupling engages acomplementary electrical coupling within coupling member 35 (and whichis in electrical communication with cooling unit 40). Alternatively, thesensor may be wireless, and the processor of cooling unit 40 equipped toreceive wireless signals from the sensor.

Alternatively or in addition, a temperature sensor may be located withincooling unit 40 to monitor the temperature of incoming fluid through oneof the fluid lines 50. The relationship between fluid temperature at thesensor and the temperature of engagement member 20 may be determined bycalibration, and the output of the sensor once again used in aclosed-loop configuration to achieve and maintain a desired estimatedtemperature at engagement member 20.

The processor may be provided as either software, hardware, or somecombination thereof. For example, the processor and control circuitrymay be based on a server-class computer, such as a PC having a CPU boardcontaining one or more processors such as the Core Pentium or Celeronfamily of processors manufactured by Intel Corporation of Santa Clara,Calif. The processor may also include a main memory unit for storingprograms and/or data relating to the feedback control described aboveand more generally to operation of the cooling unit 40 during aprocedure. The memory may include random access memory (RAM), read onlymemory (ROM), and/or FLASH memory residing on commonly availablehardware such as one or more application specific integrated circuits(ASIC), field programmable gate arrays (FPGA), electrically erasableprogrammable read-only memories (EEPROM), programmable read-onlymemories (PROM), or programmable logic devices (PLD). In someembodiments, the programs may be provided using external RAM and/or ROMsuch as optical disks, magnetic disks, as well as other commonly usedstorage devices. For embodiments in which the control functions areimplemented by a software program, the program may be written in any oneof a number of high level languages such as FORTRAN, PASCAL, JAVA, C,C++, C#, LISP, PERIL, BASIC, PYTHON or any suitable programminglanguage. Additionally, the software can be implemented in an assemblylanguage and/or machine language directed to a microprocessor.

During use, the engagement member 20 of cooling device 15 makes contactwith the surface tissue overlying the adipose tissue of the pharyngealwall. In exemplary embodiments, engagement member 20 may be placed incontact with the surface tissue for approximately one to thirty minutes.In particular embodiments, engagement member 20 may placed in contactwith the surface tissue for approximately 15 minutes. As noted above,cooling device 15 can be cooled to and maintained at a temperaturebetween approximately 0° C. and −20° C. (or, more generally, betweenapproximately −25° C. and 5° C., typically at a selected temperaturethat is kept within a clinical tolerance range, e.g., +10% or ±5%)during this contact time. The temperature and time should be sufficientto cause cryolysis of adipose tissues and selectively remove or reducefat cells from the tissues in the pharyngeal wall; as mentioned earlier,this effect need not be immediate. Reducing the volume of adipose tissuein the pharyngeal wall eliminates or reduces OSA symptoms for thepatient.

In certain embodiments, cooling device 15 may include a vacuum unit thatprovides suction at the engagement member 20 to enhance and maintainmechanical contact with the tissue of the pharyngeal wall. This may alsoprovide a greater effective surface area of contact. For example,suction may be provided by a third lumen running along shaft member 30but fluidly separate from the lumens through which cooling fluidcirculates. The contact surface of engagement member 20 may beperforated to permit the suction to exert its effect acrosssubstantially the entire area of the contact surface, with theperforations being small enough to avoid actually drawing the tissuetherein and risking damage. The feedback circuitry discussed above canmonitor the applied suction both to prevent excessive force from beingapplied as well as to indicate to the clinician the adequacy of contactbetween the engagement member 20 and the pharyngeal tissue. This suctioncapability may be employed in any of the embodiments shown in FIGS. 1-3.

Refer now to FIG. 2, which illustrates a cooling device 115 that issimilar to cooling device 15 described above. In this embodiment coolingdevice 115 comprises a shaft portion 130 and an engagement member 120.Engagement member 120 has a “V” shape or “U” shape configured to engagethe soft palate or uvula. During use, cooling device 115 operatessimilar to cooling device 15, with the exception that the area treatedis in the soft palate and/or uvula, rather than the pharyngeal wall. Theengagement member 120, in other words, is uvula-shaped or configured soas to be able to receive and retain the uvula or portion thereof. In oneembodiment, the engagement member 120 is configured to be manipulablefrom an open configuration, which allows the clinician to convenientlycup the uvula within the engagement member 120, to a closed position thesurrounds the uvula more snugly. This can be achieved, for example,using a hinged engagement member and a stiff wire 140 that the clinicianmay extend and retract through a third lumen running along the shaftmember 130. The wire operates the engagement member so as, for example,to facilitate its hinged closure via retraction of the wire.Shape-memory alloys such as NITINOL are biocompatible and may be used toform the wire 140.

With reference now to FIG. 3, a cooling device 215 is shown that issimilar to cooling device 15 described above. In this embodiment coolingdevice 215 comprises a shaft portion 130 and an engagement member 220.Engagement member 220 has a “C” shape configured to engage the base ofthe patient's tongue—e.g., shaped to be complementary to the rearsurface of the tongue opposite the uvula. During use, cooling device 215operates in the manner described above regarding cooling device 15, withthe exception that the area treated is in the base of the tongue, ratherthan the pharyngeal wall. It is understood that the embodiments shown inFIGS. 3 and 4 can be used with or without cooling unit shown in FIG. 1.For example, the cooling device 15 may be stored in a freezer and,following its removal just prior to use, maintain its cold temperaturefor a sufficient period of time to facilitate treatment as describedherein—e.g., by incorporating an “ice pack” gel in or against theengagement member 20. Furthermore, any of the devices shown in FIGS. 1-3may hinged and operable via a wire to grasp the tissue after contact isestablished therewith.

In still other embodiments, the engagement member 20 is not rigid but isinstead flexible and conformal. For example, engagement member 20 maytake the form of a cushion, e.g., a bladder partially filled with air orother fluid so that it is soft and conforms when pressed up againstoropharyngeal structures. For example, the fluid filling the bladder maybe the same as that circulating through the shaft portion.

With reference to FIG. 4, a cooling device 350 is configured to inject acooling agent into the pharyngeal wall. In this embodiment, coolingdevice 350 comprises a shaft or needle 360 configured to pierce theoropharyngeal tissue and allow the clinican to inject therethrough acooling agent, which is held at a chilled temperature in a reservoir 370(e.g., a syringe). In other embodiments, cooling device 350 is coupledto a cooling unit similar to cooling unit 40 (shown in FIG. 1) in orderto chill the liquid to the proper temperature, and to alert theclinician when this temperature has been achieved. Injection of thecooling agent causes cryolysis of adipose tissues and selectivelyremoves or reduces fat cells from the tissues in the pharyngeal wall. Inthis embodiment, the cooling agent may be a water and glycerol mixtureor any other physiologically harmless liquid capable of being chilled tothe necessary temperature without freezing.

As shown in FIG. 5, the cooling agent may be injected into the softpalate and/or uvula rather than the pharyngeal wall. In particular, acooling device 450 comprises a shaft or needle 460 configured to injecta cooling agent stored in a reservoir 470 (e.g., a syringe). Theoperation is as described above in connection with FIG. 4.

Similarly, with reference to FIG. 6, the cooling agent may be injectedinto the base of the tongue. In particular, a cooling device 550 has anangled needle 560 shaped for convenient access to the area to betreated; once again the cooling agent is stored in a reservoir 470(e.g., a syringe), and the operation is as described above in connectionwith FIG. 4.

In other embodiments, the tissue to be treated is cooled by means ofexposure to chilled air rather than by mechanical contact or injectionof a liquid. With reference to FIG. 7, cold air 620 be delivered to theoropharynx via an intraoral tube 650 and/or an intranasal tube 660(e.g., a nasal cannula). It is understood that certain embodiments mayuse only an intraoral tube 650, while others may use an intranasal tube660, while still other embodiments may use both. If cold air 620 isadministered through the nasal cavity, the mouth will be closed tomaintain the cool temperature. If the cold air is delivered intraorally,the nose will be occluded.

This can be accomplished with the patient awake or under generalanesthesia. In certain embodiments, an intubation cuff 670 with aninflatable member 680 can be used to seal the esophagus and prevent coldair from entering the lower respiratory tract. Breathing air can besupplied to the lungs through the intubation cuff 670. The progress ofthe cooling procedure may be monitored by means of a temperature sensorwithin the oropharynx, in contact with the tissue to be treated, orintroduced via a needle into the interior of that tissue.

In certain embodiments, the cold air is continuously delivered throughone conduit and withdrawn via a proximally located conduit to maintain atemperature of approximately −20 to approximately 0° C. in theoropharynx. More generally the temperature in the oropharynx may bemaintained between approximately −25° C. and 5° C., typically at aselected temperature that is kept within a clinical tolerance range,e.g., ±10% or ±5%. The inlet and outlet conduit orifices can be disposedrelative to each other such that the entire region of interest ismaintained at the desired temperature. In certain embodiments, the coldair will be administered from between approximately 1 minute toapproximately 75 minutes; the specific amount of time depends on thepatient's anatomy (i.e., the target amount of adipose tissue reduction)and clinical factors determined to bear on the likely responsiveness ofthe patient's tissue to treatment.

Alternatively, as depicted in FIGS. 8A-8C, rather than utilizingseparate air delivery and withdrawal tubes, a dual-lumen tubular member800 that provides both cold air 820 to the oropharynx and breathing air825 to the lower respiratory tract may be employed. An inflatable member830 can be used to seal the esophagus so that cold air 820 is restrictedfrom entering the lower respiratory tract. In certain embodiments,dual-lumen tubular member 800 comprises an outer lumen 860 that allowscold air 820 to enter the oropharynx, and an inner lumen 865 that allowsbreathing air 825 to be delivered to the lower respiratory tract via aport 867. The tube 870 surrounding the inner lumen 865 includes theinflatable member 830 and is longer than the tube 875 surrounding theouter lumen 860, from which cold air 820 exits. As shown in FIG. 8C,these coaxial tubes 870, 875 may be kept separate (to establish andmaintain the outer lumen 860) by means of ribs 880 running between thetubes. An inflation tube 885 running along the inner 870 (but fluidlyindependent thereof) facilitates inflation of the inflation member 830by the clinician, e.g., via a bulb or by a pump within cooling unit 40.This configuration may be used in the embodiments shown in FIGS. 7 and 9as well.

With reference now to FIG. 9, a cold liquid 920 can be administered toan intubated patient in a manner similar to cold air in the embodimentsshown in FIGS. 7 and 8. In exemplary embodiments the liquid isbiocompatible with a freezing point less than water, e.g., an aqueousglycerin solution. The oral cavity/oropharynx is filled with the coldliquid 920, and an inflatable member 925 is inflated on the intubationtube 900 to prevent aspiration. The liquid may be continuouslyreplenished or left in place. In certain embodiments, the temperature ofliquid 920 is approximately −20 to approximately 0° C., or moregenerally, maintained between approximately −25° C. and 5° C., typicallyat a selected temperature that is kept within a clinical tolerancerange, e.g., ±10% or ±5%. Between approximately −20 and approximately 0°C. and left in place or continually circulated for approximately 1minute to approximately 75 minutes; the specific amount of time dependson the patient's anatomy (i.e., the target amount of adipose tissuereduction) and clinical factors determined to bear on the likelyresponsiveness of the patient's tissue to treatment.

The various illustrative embodiments of devices, systems, and methodsdescribed herein are not intended to be limited to the particular formsdisclosed. Rather, they include all modifications and alternativesfalling within the scope of the claims. The claims are not intended toinclude, and should not be interpreted to include, means-plus- orstep-plus-function limitations, unless such a limitation is explicitlyrecited in a given claim using the phrase(s) “means for” or “step for,”respectively.

What is claimed is:
 1. A method for treating obstructive sleep apnea ina subject, the method comprising steps of: contacting a target surfaceof an oropharyngeal tissue or an underlying tissue in a subject withobstructive sleep apnea with a cooling surface or a cooling fluid;cooling the target surface of the oropharyngeal tissue or the underlyingtissue in the subject with obstructive sleep apnea for a time sufficientto cause cryolysis of adipose tissue within the oropharyngeal tissue;and reducing a volume of the adipose tissue within the oropharyngealtissue.
 2. The method of claim 1, wherein the target surface of theoropharyngeal tissue includes one or more of: a soft palate, a uvula, atongue, or a pharyngeal wall.
 3. The method of claim 1, wherein thecooling surface is configured to be placed in contact with the surfaceof the oropharyngeal tissue between approximately one minute andapproximately thirty minutes to cause cryolysis of adipose tissue withinthe oropharyngeal tissue.
 4. The method of claim 1, wherein cooling thetarget surface of the oropharyngeal tissue or the underlying tissue inthe subject with obstructive sleep apnea for a time sufficient to causecryolysis of adipose tissue within the oropharyngeal tissue includescooling the adipose tissue to a temperature of between about 0° C. and abody temperature.
 5. The method of claim 1, wherein the cooling surfacecomprises a tissue engagement member.
 6. The method of claim 5, whereincontacting the target surface of the oropharyngeal tissue in the subjectwith obstructive sleep apnea further comprises: cooling the tissueengagement member to a temperature between approximately 5° C. andapproximately −25° C. and placing the tissue engagement member incontact with the target surface of the oropharyngeal tissue in thesubject.
 7. The method of claim 5, wherein the tissue engagement membercomprises a flexible and conformal material.
 8. The method of claim 5,wherein the tissue engagement member comprises a complementary surfaceto the target surface of the oropharyngeal tissue.
 9. The method ofclaim 6, further comprising: cooling the tissue engagement member to thetemperature between approximately 5° C. and approximately −25° C. with athermoelectric cooler.
 10. The method of claim 6, further comprising:circulating a chilled fluid through an internal portion of the tissueengagement member to cool the tissue engagement member to thetemperature between approximately 5° C. and approximately −25° C. 11.The method of claim 6, further comprising: providing a negative pressureto the target surface of the oropharyngeal tissue to improve heattransfer between the target surface of the oropharyngeal tissue and thetissue engagement member.
 12. The method of claim 1, wherein contactingthe target surface of the oropharyngeal tissue or the underlying tissuein the subject with obstructive sleep apnea with the cooling surface orcooling fluid further comprises: piercing the target surface oforopharyngeal tissue in the subject with a needle.
 13. The method ofclaim 12, further comprising: injecting a cooling fluid through a lumenof the needle into the oropharyngeal tissue to cause cryolysis ofadipose tissue within the oropharyngeal tissue.
 14. The method of claim13, wherein the needle is in fluid communication with a cooling unit forchilling a cooling fluid, and further comprising: chilling the coolingfluid with the cooling unit prior to injecting the cooling fluid throughthe lumen of the needle.
 15. The method of claim 1, wherein contactingthe target surface of the oropharyngeal tissue or the underlying tissuein the subject with obstructive sleep apnea with the cooling surface orcooling fluid includes contacting a chilled air with the oropharyngealtissue.
 16. The method of claim 15, further comprising: administeringthe chilled air into the oropharynx through a tube for the timesufficient to cause cryolysis of adipose tissue within oropharyngealtissue of the subject.
 17. The method of claim 16, wherein the tube isin fluid communication with a cooling unit for chilling the chilled air,and further comprising: cooling the chilled air with the cooling unitprior to administering the chilled air into the oropharynx.
 18. Themethod of claim 15, further comprising: introducing the tube through anasal passage of the patient.
 19. The method of claim 15, furthercomprising: introducing the tube through a mouth of the patient.
 20. Themethod of claim 15, further comprising: inflating an inflatable memberto seal an esophagus of the patient to prevent chilled air from enteringa lower respiratory tract of the patient.
 21. The method of claim 15,wherein the time sufficient to cause cryolysis of adipose tissue withinthe oropharyngeal tissue is a period between approximately one minuteand approximately 75 minutes.
 22. The method of claim 1, whereincontacting the target surface of the oropharyngeal tissue or theunderlying tissue in the subject with obstructive sleep apnea with thecooling surface or cooling fluid includes contacting a chilledbiocompatible liquid with the oropharyngeal tissue.
 23. The method ofclaim 22, further comprising: filling an oral cavity/oropharynx of thesubject with the chilled biocompatible liquid; and concurrentlyinflating an inflatable member so that the inflatable member seals anesophagus of the patient thereby preventing aspiration of the chilledbiocompatible liquid.
 24. The method of claim 1, wherein reducing thevolume of the adipose tissue within the oropharyngeal tissue includesremoving a fatty tissue.
 25. The method of claim 1, further comprising:piercing a pharyngeal wall and injecting the cooling fluid in thepharyngeal wall to contact the underlying tissue with the cooling fluid.26. A method for treating obstructive sleep apnea in a subject, themethod comprising steps of: contacting a target surface of anoropharyngeal tissue or an underlying tissue in a subject withobstructive sleep apnea with an applicator comprising a needle; coolingthe target surface of the oropharyngeal tissue or the underlying tissuein the subject with obstructive sleep apnea with the needle for a timesufficient to cause cryolysis of adipose tissue within the oropharyngealtissue; and reducing a volume of the adipose tissue within theoropharyngeal tissue.
 27. The method of claim 26, further comprising:piercing the target surface of oropharyngeal tissue in the subject witha needle.
 28. The method of claim 26, further comprising: injecting acooling fluid through a lumen of the needle into the oropharyngealtissue to cause cryolysis of adipose tissue within the oropharyngealtissue.
 29. The method of claim 28, wherein the needle is in fluidcommunication with a cooling unit for chilling a cooling fluid, andfurther comprising: chilling the cooling fluid with the cooling unitprior to injecting the cooling fluid through the lumen of the needle.